This article will explain all you need to know about registering your products with the National Agency for Food & Drug Administration and Control (NAFDAC) in the year 2022. NAFDAC is the administrative body in charge of issuing authorization for the importation, exportation, production, and registration of food and medicine commodities like pharmaceuticals, edible products, perfumes, medical, and diagnostic supplies, among other things, that are manufactured in or out of Nigeria’s borders.
Before registering their goods with NAFDAC, many companies that process, produce, and sell nutritional products, foreign-made food products, semi-processed meals, medicine, and skincare products must first incorporate with the Corporate Affairs Commission (CAC).
There are two methods for carrying out the registration of your products with NAFDAC, and they are as follows:
- Request NAFDAC for approval to import a sample of foodstuffs and/or pharmaceutical goods made outside of Nigeria. Importers will be given formally signed clearance by NAFDAC to import samples of their goods into Nigeria for this particular application.
- Request NAFDAC for authorization of locally produced or foreign-made food and/or pharmaceutical goods.
It’s worth noting that the second form of registration that is available for locally manufactured goods differs slightly from the registration procedure for imported products. Also, keep in mind that if a company manufactures many items, it will be required to register each of them differently in order to be granted the NAFDAC reg number for the various products.
REQUIREMENTS FOR GETTING A NAFDAC REG NUMBER IN NIGERIA FOR YOUR PRODUCTS
If you wish to carry out registration for your products with NAFDAC so that you can get a special NAFDAC reg number in Nigeria today, be aware that the documentation you’ll need for registration will mostly rely on whether they’re food or drugs. Please keep in mind that NAFDAC has the last say over whether or not to grant your product with a registration certificate and number. You will almost certainly be awarded a NAFDAC reg number if your product satisfies their assurance, safety and regulatory tests.
As a result, the following are the prerequisites for NAFDAC registration of your food items and pharmaceutical products:
- An official written application letter for the registration of your product(s) addressed to the Director, Registration and Regulatory Affairs, NAFDAC stating the name of the manufacturer, brand name, and product.
- Fill out the authorized NAFDAC Application Form D-REG/001.
- Provide proof of payment of specified fees.
- Provide a Certificate of Incorporation for your company
- Provide a certificate of inspection or recognition issued by NAFDAC
- If the product is imported, you are to provide the original copy of the Power of Attorney from the product manufacturer
- Provide the trademark registered in Nigeria for your brand name
- If your products are drugs only, you are to provide a signed and endorsed certificate of the pharmaceutical product.
- Where applicable, you are to provide a letter of invitation from the manufacturer to inspect the factory abroad, full name, and site of the plant.
- Provide a pack of your product samples for quality analysis and inspection.
- Provide a signed and sealed declaration of a duly executed power of attorney from the product manufacturer, which is required to be type-filled and notarized by a Notary Public here in Nigeria.
- Also required is a Certificate of Free Sale that is to be obtained and issued from the relevant health and regulatory body in the manufacturer’s country showing the Manufacturer’s name and product(s) to be registered. This certificate must be authenticated by the Nigerian Embassy in the country of origin. In countries with no Nigerian Embassies or High Commissions, any other Embassy or High Commission of any Commonwealth or West African country can authenticate this document.
- Provide a comprehensive Certificate of Analysis. This certificate of analysis must be presented on a letter headed paper of the quality control laboratory where the sample was tested or evaluated, and it should contain the following information: The brand name of the product, the batch number of the product, the manufacturing and expiry dates, the name, designation, and signature of the analyst.
- Application letter for Import Permit by the applicant (this applies to a locally registered company).
- Evidence of warehouse acquisition (where applicable)
- Coloured Artwork or Label of the product and leaflet insert of the product.
- Evidence of Good Manufacturing Practices (GMP) inspection.
- Manufacturer Information includes the name of the company, contact details of the factory which must capture the address, email address, current phone number and fax number, the name of the contact person overseas, telephone number, email address, etc. Also important is the name of the airport closest to the location and a guide map illustrating the shortest land/air route to the factory overseas.
- Local Agent Information such as the name of the locally registered company that will take immigration responsibility; full location address, functional telephone number, and email address.’
You must know that NAFDAC has the authority to certify certain products without granting them a Reg Number. You will need to secure an importation license or clearance from the agency if you want to register imported items without obtaining a NAFDAC reg number. The following are the prerequisites for getting an import license from NAFDAC:
- Application for an import permit with the payment of specified fees.
- A neat warehouse for NAFDAC inspection.
- Technical Officer with background knowledge in the field of science with a passport photograph of the Technical Officer.
- Certificate of Incorporation of the local company with the Corporate Affairs Commission.
- Certificate of Analysis of the products.
- Local Purchase Order.
- Material Safety Data Sheet.
For additional details on ways to register your items with NAFDAC, visit the agency’s online platform.
Is NAFDAC registration compulsory?
NAFDAC registration is compulsory for anyone in the production and distribution of regulated products.
What are some examples of regulated products:
medicines, foods, medical instruments (diapers, sanitary pads, and other health-related products), perfumes, insecticides, detergents, drinks, and bottled and packaged water
Will I need a NAFDAC number if I’m going into food processing, such as selling processed foods like packaged garri?
Yes, you’ll need to register. NAFDAC has a new fast-track registration scheme for food processing businesses that will help them get registered on time.
What are the benefits of getting NAFDAC number?
The following are some of the advantages of getting a NAFDAC registration for your products:
First of all, it is acting in accordance with the laws of this country and protecting your business as non-compliance could result in a complete shut-down of your business. It also has very effective promotional rewards as it helps boost trust in your product. NAFDAC has done an excellent job of educating the public about the importance of double-checking that products have a NAFDAC number before using them, especially when it comes to food and medicine. So for a new business, getting the NAFDAC number will encourage other businesses and your buyers to treat you with sincerity and respect.